J Lab Med Qual Assur.
2010 Dec;32(2):197-204.
Evaluation of Cheongmeak DCS(TM) Reagents for Chemistry Analyzers
- Affiliations
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- 1Department of Laboratory Medicine, Chungbuk National University College of Medicine, Cheongju, Korea. ksshin@chungbuk.ac.kr
Abstract
- BACKGROUND
The evaluation of newly developed reagents for chemical analyzer is essential for an accurate testing of various samples. We evaluated the analytical performance of the DCS(TM) reagents (Cheongmeak, Korea).
METHODS
Fifteen chemistry reagents of alanine aminotransferase (ALT), aspartate aminotransferase (AST), gamma glutamyl transferase (GGT), alkaline phosphatase (ALP), total bilirubin, total protein, albumin, blood urea nitrogen (BUN), creatinine, glucose, calcium, inorganic phosphorus, total cholesterol, triglyceride and HDL-cholesterol were tested for precision, linearity and correlation according to CLSI guidelines in the Hitachi 7180 chemistry analyzer (Hitachi High-Technologies Co., Japan).
RESULTS
The coefficients of variation (CV) of both within-run and total precision were below 3.98% for all analytes, which fully meets of CLIA 88 decision ranges. Good linearity was shown for all analytes in measurement ranges. Coefficients of correlation were also good for all analytes.
CONCLUSIONS
DCS(TM) reagents showed good precision, linearity and correlation. Therefore, the DCS(TM) reagents could be acceptable for use in routine chemistry analyzers.